Clinical Significance of 64-slice Multidetector Coronary CT Angiography to Evaluate the Prevalence and Severity of Coronary Artery Disease in Renal Transplant Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01753505
First received: December 17, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

The aim of this study is to evaluate the clinical usefulness of 64-slice multidetector coronary CT angiography (MDCTA) in renal transplant recipients who had no previous coronary artery disease (CAD). Primary endpoint is to assess the prevalence and severity of coronary artery disease in patients post-transplant 6 to 12 months. CAD can be diagnosed noninvasively with similar accuracy of coronary angiography using MDCTA. Early detection and intervention of CAD may provide survival benefit in renal transplant recipients.


Condition Intervention
Kidney Transplant Recipient
Other: 64-slice Multidetector coronary CT angiography

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • prevalence of coronary artery disease [ Time Frame: at post-transplant 6 to 12 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • severity of coronary artery disease [ Time Frame: at post-transplant 6 to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDCTA Other: 64-slice Multidetector coronary CT angiography

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age ≥ 40 yrs
  2. renal transplant recipient at post-transplant 6 to 12 months
  3. stable graft renal function: CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation ≥45 mL/min/1.75m2
  4. patients who had no previous CAD

Exclusion Criteria:

  1. unstable graft renal function
  2. History of acute kidney injury within 3 months
  3. Allergic history to contrast agent
  4. Irregular heart beat
  5. Multiorgan transplant recipients
  6. Pregnancy
  7. Patients who do not consent to this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753505

Contacts
Contact: Beom Seok Kim, MD 82-2-2228-1969 docbsk@yuhs.ac

Locations
Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Beom Seok Kim, MD    82-2-2228-1969    docbsk@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01753505     History of Changes
Other Study ID Numbers: 4-2012-0549
Study First Received: December 17, 2012
Last Updated: February 17, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
multidetector coronary CT angiography, renal transplantation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014